Reentry catheter and method thereof

• US 8,998,936 B2
• Filed: 09/09/2011
• Issued: 04/07/2015
• Est. Priority Date: 06/30/2011
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Alvarez, Jeffery B., Nevrla, David S.
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US13/229,392
• Publication Number:
  US 20130006167A1
• Time in Patent Office: 1,306 Days
• Field of Search: 606/108, 606/159, 606/167, 606/185, 606/194, 60416401-16413, 291/08, 291/59, 291/67, 291/85, 291/94
• US Class Current: 606/159
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0058 having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

Claims

1. A catheter system, comprising:

a catheter body having a proximal end, a distal end, at least one lumen running from the proximal end through the distal end, and a lateral opening disposed on a periphery of the catheter body and in communication with the at least one lumen; and

a reentry member comprising a distal end and at least one sharp edge and at least one void space in a circumferential portion of the reentry member that is configured to enable flexing from a first position inside the at least one lumen to a second position outside of the at least one lumen and through the lateral opening of the catheter body when an axial eccentric load is placed at a distal portion of the reentry member, wherein the distal end of the reentry member comprises a tear drop shaped cross section tapering to form the at least one sharp edge, wherein the at least one sharp edge comprises a longitudinal axis, wherein the at least one void space is disposed along the longitudinal axis.

2. The catheter system of claim 1, wherein the axial eccentric load is applied with at least one of a control wire, a cabling device, a ramp, and an elastomeric member.

3. The catheter system of claim 1, wherein the reentry member comprises a material selected from the group consisting of an electroactive polymer, a thermo-active polymer, an electroactive metal and combinations thereof.

4. The catheter system of claim 3, wherein the axial eccentric load is applied with an electrical signal applied to the reentry member.

5. The catheter system of claim 1, wherein the reentry member comprises a pre-resilient shape.

6. The catheter system of claim 1, wherein the reentry member comprises a material selected from the group consisting of stainless steel, nitinol, alloy, titanium, thermoplastics, polyether ether ketone (PEEK), polyimide, and combinations thereof.

7. The catheter system of claim 1, wherein the catheter body further comprises a second lumen, wherein the second lumen is configured to receive a guide wire having a diameter in a range from about 0.01 inches to about 0.04 inches.

8. The catheter system of claim 1, wherein the catheter body comprises a material selected from the group consisting of a polyester, a polyurethane, a polyamide, a polyolefin, a polyethylene, a polypropylene, a nylon, a polyester elastomer, a polyether/block polyamide, a Hytrel, a polyamide, a flouro-polymer, a polyether ether ketone, a polyethylene, a polyurethane, a polyolefin copolymer, a tetrafluoroethylenes, a polytetrafluoroethylene, a steel, a laser cut stainless steel and combinations thereof.

9. The catheter system of claim 1, wherein the at least one lumen of the catheter body is configured to receive a supplemental treatment device.

10. The catheter system of claim 9, wherein the supplemental treatment device is selected from the group consisting of a guide wire, a medical instrument, a balloon, a stent, a laser catheter, a medication, an optical catheter and combinations thereof.

11. The catheter system of claim 1, further comprising at least one radiopaque marker arranged on a distal portion of at least one of the reentry member and the catheter body.

12. The catheter system of claim 1, wherein the at least one void space comprises a plurality of cut out sections.

13. The catheter system of claim 12, wherein the plurality of cut out sections comprise at least one of the following geometrical configurations:

a tear drop configuration, a diamond configuration, a square configuration, a pentagon configuration, a hexagon configuration and combinations of the same.

14. The catheter system of claim 1, further comprising an exchange port arranged on at least distal portion of the catheter body, wherein the exchange port comprises at least one lumen configured to receive a guidewire and the catheter body is configured to track over the guidewire to a treatment site.

15. A reentry catheter for use in forming a pathway in an interstitial space of an artery, comprising:

a catheter body including a proximal end, a distal end, at least one lumen running from the proximal end through the distal end;

an exchange port arranged on at least a distal portion of a periphery of the catheter body, wherein the exchange port comprises at least one lumen configured to receive a guidewire and the catheter body is configured to track over the guidewire to a treatment site;

a reentry member having a proximal end, a distal end, at least one lumen extending from the proximal end to the distal end, wherein the distal end includes a tear drop shaped cross section tapering to form a sharp surface to permit cutting, wherein the sharp surface comprises a longitudinal axis, wherein at least one void space is disposed along the longitudinal axis, and wherein the reentry member is configured to be slidably advanced within the at least one lumen of the catheter body; and

a tether coupled to a distal end portion of the reentry member, wherein the distal end portion of the reentry member is configured to deploy through at least one port of the catheter body from a first location within the interstitial space of the artery to a second location within a true lumen of the artery upon application of a force to the tether.

16. A method of crossing an obstruction in a blood vessel, comprising the steps of:

advancing a first guide wire into a lumen of the vessel towards the obstruction in the vessel;

advancing the first guide wire into a subintimal space of the vessel to a location distal of the obstruction;

advancing a catheter having at least one lumen and comprising a reentry member over the guide wire to a location where a port disposed on a periphery of the catheter is at a location distal of the obstruction, wherein the reentry member comprises a distal end and at least one sharp edge and at least one void space in a circumferential portion of the reentry member configured to enable flexing from a first position inside the at least one lumen to a second position outside of the at least one lumen and through the port of the catheter when an axial eccentric load is placed at a distal portion of the reentry member, wherein the distal end of the reentry member comprises a tear drop shaped cross section tapering to form the at least one sharp edge, wherein the at least one sharp edge comprises a longitudinal axis, wherein the at least one void space is disposed along the longitudinal axis; and

cutting with the at least one sharp edge of the reentry member from a first location within the subintimal space of the vessel through the port to a second location within a true lumen of the vessel.

17. The method of claim 16, further comprising the steps of:

returning the reentry member from the second location to the first location; and

removing the reentry member from the vessel.

18. The method of claim 16, wherein the cutting step comprises inflating an elastomeric member.

19. The method of claim 16, wherein the cutting step comprises applying an electrical signal to the reentry member.

20. The method of claim 16, wherein the cutting step comprises applying a force to a control wire, cable, or tether element.